Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females

• Naive to Growth Hormone treatment

Exclusion Criteria:

• Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.